Back to results

Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Abiraterone Acetate

Prednisone

LHRHa

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Neoadjuvant Prostate Cancer, Abiraterone Acetate, LHRHa, high risk prostate cancer, Radical prostatectomy, Prednisone, Luteinizing Hormone-Releasing Hormone, LHRH analogue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Histological proof of prostatic adenocarcinoma via a minimum of 6 core biopsy samples
Clinical stage T1c or T2 with high-grade disease (Gleason's 8-10) on initial biopsy, or clinical stage T2b-T2c with Gleason's grade >/= 7 and PSA > 10ng/ml.
No evidence of metastatic disease as determined by CT scans and bone scans.
Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1
Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (ANC) > 1,500 and platelet count of > 100,000.
Normal pituitary and adrenal function
Patients should be deemed to be candidates for radical prostatectomy.

Exclusion Criteria:

Histological variants in the primary tumor (histological variants other than adenocarcinoma); neuroendocrine tumor
Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
Uncontrolled hypertension
Abnormal Liver function
Active or symptomatic viral hepatitis or chronic liver disease
Clinically significant heart disease
Other active malignancy
History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
Previous treatment with abiraterone acetate
Patients who are not appropriate surgical candidates for radical prostatectomy
Prior chemotherapy or radiation therapy for prostate cancer.
Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study

Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

AA+LHRHa

LHRHa

Arm Description

Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy.

Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.

Outcomes

Primary Outcome Measures

Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2)

The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2.

Secondary Outcome Measures

Number of Participants With a Positive Surgical Margin at Radical Prostatectomy

The table below shows number of participants in each treatment group who had positive surgical margins. A positive surgical margin is defined as tumor extending to the inked-surface or margin of the prostate.

Number of Participants With Prostate-Specific Antigen Response

The table below shows number of participants in each treatment group who achieved a prostate-specific antigen (PSA) response defined as a drop in PSA value to less than or equal to 0.2 ng/mL.

Full Information

NCT ID

NCT01088529

First Posted

March 15, 2010

Last Updated

May 1, 2014

Sponsor

Cougar Biotechnology, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01088529

Brief Title

Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer

Official Title

A Randomized, Open-Label, Neoadjuvant Prostate Cancer Trial of Abiraterone Acetate Plus LHRHa Versus LHRHa Alone

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cougar Biotechnology, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The goal of this clinical research study is to find out how treatment with abiraterone acetate in combination with prednisone and a Luteinizing Hormone-Releasing Hormone (LHRH) analogue changes the tumor in comparison to treatment with an LHRH analogue alone. Objectives: Primary Objective: To assess the difference in pathologic stage < pT2 between Group A and Group B. Secondary Objective: To assess and compare the changes in levels of androgens (pre, during, and post treatment) in the serum, primary tumor microenvironment and bone marrow between Group A and Group B. To assess changes in biomarkers related to androgen signaling and other cancer-related pathways between Group A and Group B. To assess the difference in rate of positive surgical margins between Group A and Group B. To assess the safety profile of abiraterone acetate and low dose prednisone in a preoperative setting.

Detailed Description

Study Groups: Participants who are eligible to take part in this study will be randomly assigned (as in the flip of a coin) to 1 of 2 groups: Those who are in Group A will take abiraterone acetate, a LHRH analogue, and prednisone. Those who are in Group B will receive a LHRH analogue alone. Participants will have 2 out of 3 chances of being placed in Group A or 1 out of 3 chances of being placed in Group B. Participants in both groups will receive the study drug(s) for about 3 months followed by a prostatectomy (prostate surgery) between 2 and 4 weeks after they stop taking the study drug(s). Length of Study: Participants will receive study drugs on this study for about 3 months before having surgery to remove their prostate about 2-4 weeks later. Participants will be removed from this study if the disease gets worse, if they experience intolerable side effects, or their study doctors feel that it is in their best interest to stop the study. Long-Term Follow-Up: Participants will return to the clinic 1 month, 3 months, 6 months, and then every 6 months (for up to 8 years) after your surgery for follow-up visits. Up to 66 patients will be take part in this study. All will be enrolled at M. D. Anderson after their surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Neoadjuvant Prostate Cancer, Abiraterone Acetate, LHRHa, high risk prostate cancer, Radical prostatectomy, Prednisone, Luteinizing Hormone-Releasing Hormone, LHRH analogue

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AA+LHRHa

Arm Type

Experimental

Arm Description

Arm Title

LHRHa

Arm Type

Experimental

Arm Description

Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.

Intervention Type

Drug

Intervention Name(s)

Abiraterone Acetate

Other Intervention Name(s)

CB7630

Intervention Description

1000 mg oral daily for 3 months followed by a prostatectomy.

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

5 mg orally daily.

Intervention Type

Drug

Intervention Name(s)

LHRHa

Other Intervention Name(s)

Lupron®, leuprolide, Zoladex®, goserelin

Intervention Description

LHRH analogue (either leuprolide or goserelin): Leuprolide is an intramuscular injection, and goserelin subcutaneous (under skin) of abdomen, given either 1 injection every 3 months or 1 injection each month for 3 months.

Primary Outcome Measure Information:

Title

Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2)

Description

The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2.

Time Frame

At the end of Cycle 3 (at radical prostatectomy)

Secondary Outcome Measure Information:

Title

Number of Participants With a Positive Surgical Margin at Radical Prostatectomy

Description

Time Frame

At the end of Cycle 3 (at radical prostatectomy)

Title

Number of Participants With Prostate-Specific Antigen Response

Description

The table below shows number of participants in each treatment group who achieved a prostate-specific antigen (PSA) response defined as a drop in PSA value to less than or equal to 0.2 ng/mL.

Time Frame

Cycle 3 Day 1

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological proof of prostatic adenocarcinoma via a minimum of 6 core biopsy samples Clinical stage T1c or T2 with high-grade disease (Gleason's 8-10) on initial biopsy, or clinical stage T2b-T2c with Gleason's grade >/= 7 and PSA > 10ng/ml. No evidence of metastatic disease as determined by CT scans and bone scans. Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1 Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (ANC) > 1,500 and platelet count of > 100,000. Normal pituitary and adrenal function Patients should be deemed to be candidates for radical prostatectomy. Exclusion Criteria: Histological variants in the primary tumor (histological variants other than adenocarcinoma); neuroendocrine tumor Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection Uncontrolled hypertension Abnormal Liver function Active or symptomatic viral hepatitis or chronic liver disease Clinically significant heart disease Other active malignancy History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug Previous treatment with abiraterone acetate Patients who are not appropriate surgical candidates for radical prostatectomy Prior chemotherapy or radiation therapy for prostate cancer. Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cougar Biotechnology, Inc. Clinical Trial

Organizational Affiliation

Cougar Biotechnology, Inc.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Christopher Logothetis, MD

Organizational Affiliation

UT MD Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

City

Houston

State/Province

Texas

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.cancer.gov

Description

NATIONAL CANCER INSTITUTE

URL

http://www.nlm.nih.gov/medlineplus/prostatecancer.html

Description

NATIONAL INSTITUTE OF HEALTH

Learn more about this trial

Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer

We'll reach out to this number within 24 hrs